Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.64 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.064 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
0.8 mg/L
Assessment factor:
1
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
59.705 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
5.97

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met.

Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint”.

 

Since the group concept is applied to the members of the Glycerides category, data will be generated from a representative category member to avoid unnecessary animal testing. Additionally, once the group concept is applied, substances will be classified and labelled on this basis.

 

Classification related key information

 

Biodegradation in water: screening tests:   64% in 28 days (ISO 10708)(read-across).

 

Bioaccumulation: No significant bioaccumulation in biota is expected for this substance (see IUCLID section 5.3).

 

Acute toxicity:

Fish:   

LC50 (96 h)(Danio rerio): > 10000 mg/L (nominal)(ISO 7346-1)(read-across).

Aquatic invertebrates:

EL50 (48 h)(Daphnia magna): > 100 mg/L (nominal, loading rate)(OECD 202).

Algae:

ErL50 (72 h)(Desmodesmus subspicatus): > 320 mg/L (nominal, loading rate)(OECD 201)(read-across).

 

Chronic toxicity:

Aquatic invertebrates:

NOELR (21 d)(Daphnia magna): ≥ 10 mg/L (nominal, loading rate)(OECD 211)(read-across). 

Algae:

NOELR (72 h)(Desmodesmus subspicatus): 32 mg/L (nominal, loading rate, above the water solubility of the substance (WS < 0.1 mg/L)(OECD 201)(read-across). 

 

Non-classification justification according to CLP

Based on the data above, isooctadecanoic acid, mono- and diester with glycerol (CAS No. 97358-80-0) is considered to be rapidly degradable and have low potential for bioaccumulation. The acute L(E)C50 values reported for fish, aquatic invertebrates and algae are > 1 mg/L. Therefore, isooctadecanoic acid, mono- and diester with glycerol does not need to be classified and labelled as acute aquatic hazard according to the 2nd ATP of Regulation (EC) No.1272/2008 (CLP).

 

Valid chronic toxicity data are available, with NOEC values (for aquatic invertebrates and algae) > 1 mg/L.Thus, isooctadecanoic acid, mono- and diester with glycerol does not need to be classified and labelled as long-term aquatic hazard according to the 2nd ATP of Regulation (EC) No.1272/2008 (CLP).

 

Non-classification justification according to DSD

Based on the data above, isooctadecanoic acid, mono- and diester with glycerol (CAS No. 97358-80-0) is considered to be rapidly degradable and have low potential for bioaccumulation. The acute L(E)C50 values reported for fish, aquatic invertebrates and algae are > 1 mg/L. Isooctadecanoic acid, mono- and diester with glycerol does not need to be classified and labeled as environmental hazard according to Directive 67/548/EEC.